A Feasibility and Preliminary Efficacy Study of an App-Based Physical Activity Intervention (MoodMover) for Depression

Официальное название

Feasibility and Preliminary Efficacy of an App-Based Physical Activity Intervention for Individuals With Depression (MoodMover): A Protocol for a Single-Arm, Pre-Post Intervention Study

Обзор

Exercise is recommended as a standalone treatment for mild-to-moderate depression in Canada. However, it's unclear how mental health practitioners can guide patients to structured, in-person exercise programs. In cases where such programs are not available or are unattractive to some, self-guided mobile health physical activity interventions could be a potential alternative. The investigators have been following a behavioural intervention development framework to create a 9-week, app-based physical activity intervention called MoodMover for people with depression. To evaluate the feasibility and preliminary efficacy of MoodMover, this study will employ a single-arm, pre-post experimental trial.

Подробное описание

MoodMover is a 9-week, app-based physical activity intervention, comprising a one-week run-in period, followed by eight major lessons, each complemented by an optional lesson, with new lessons becoming available on a weekly basis. Each major lesson addresses a specific topic designed to enhance physical activity engagement, covering topics including 1) feeling better through daily activity, 2) making physical activity enjoyable, 3) building self-confidence, 4) building physical activity opportunities, 5) developing self-regulatory skills, 6) drawing on social support, 7) forming an exercise habit, and 8) building exercise identity. Key features include step tracker, exercise logging with mood monitoring, action planning, gamification, and anonymized communications among users.

PRIMARY OBJECTIVE: This trial primarily aims to evaluate the feasibility and acceptability of MoodMover. In addition, the study will preliminarily assess the efficacy of MoodMover by monitoring changes in daily step counts, the main behavioral outcome of interest. Furthermore, the study will assess alterations in depressive symptoms and explore the association between these changes.

RESEARCH METHODOLOGY: All participants will begin by completing baseline assessments on REDCap. They will then participate in a 15-minute orientation session via Zoom with a researcher on the program's start date. The first five orientation sessions will be recorded and evaluated by an independent researcher using a fidelity checklist, allowing for immediate improvements in treatment fidelity. Following the orientation, participants will use MoodMover as directed for the duration of the 9-week program. No additional support will be offered except for technical issues. After completing the intervention, participants will undergo a follow-up assessment on REDCap. Participants will be encouraged to keep the app on their smartphones and continue using it after the program concludes. If they choose not to uninstall the app, this will be considered implied consent for the researcher to monitor their ongoing user engagement and physical activity data for an additional 9-week follow-up period. At the end of this period, participants will be contacted to sync their step data with MoodMover, enabling the collection of physical activity data throughout the follow-up. Additionally, participants will be asked to complete a satisfaction survey on REDCap.

STATISTICAL ANALYSIS: The analysis will involve (1) Descriptive statistics, (2) Regression-based analyses to evaluate the relationships between feasibility outcomes and other variables, and (3) Random effects mixed modeling to assess the impact of MoodMover on secondary outcomes and the relationship between changes in physical activity and depressive symptoms. As an underpowered single-arm feasibility study, the reporting of efficacy outcomes will focus on estimation.

Вмешательства

• Поведенческое MoodMover
  MoodMover is a 9-week app-based program aimed at increasing physical activity (PA) among individuals with depression, delivered via Pathverse. The current version of MoodMover includes one introductory module for baseline self-monitoring, eight primary modules, and eight optional supplementary modules. The program uses a variety of formats to deliver educational content, including videos, podcasts, and illustrated articles. In addition to its structured psychoeducational content, the app provide

Первичные конечные точки

• Recruitment rate assessed by the proportion of enrolled participants to those who are eligible and interested. [Срок оценки: After recruitment is completed (up to 6 months)]
• Intervention adherence assessed by the proportion of participants who complete the majority of major lessons. [Срок оценки: Post-intervention (week 10)]
• User Engagement: Time spent on each module will be downloaded from the Pathverse admin web portal. [Срок оценки: Post-intervention (week 10) and up to 18 weeks]
• Usability assessed by the adapted, patient version of the mHealth app usability questionnaire (MAUQ) for standalone apps. [Срок оценки: Post-intervention (week 10)]
• Retention rates indicated by the proportion of participants completing both pre- and post-intervention questionnaires. [Срок оценки: Post-intervention (week 10)]
• Compliance to the graded goal setting indicated by the proportion of participants who successfully set their step goals as instructed. [Срок оценки: During the intervention (weeks 2-9) and Post-intervention (week 10)]
• User satisfaction assessed by Melin et al.'s mHealth Satisfaction Questionnaire (14-item) [Срок оценки: Post-intervention (week 10) and 9-week follow-up (week 18)]

Вторичные конечные точки (12)

• Device-based physical activity assessed by the smartphone's built-in step counting function [Срок оценки: Baseline (week 1), during the intervention (weeks 1- 9), post-intervention (week 10), and follow-up (week 18)]
• Subjective physical activity assessed by the Canadian Physical Activity Adult Questionnaire (PAAQ) [Срок оценки: Enrollment (week 0) and post-intervention (week 10)]
• Depressive symptoms assessed by the Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Enrollment (week 0) and post-intervention (week 10)]
• Anxiety assessed by the Generalized Anxiety Disorder 7 scale (GAD-7) [Срок оценки: Enrollment (week 0) and post-intervention (week 10)]
• Sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Enrollment (week 0) and post-intervention (week 10)]
• Functional disability assessed by the short-version of the World Health Organization Disability Assessment Schedule 2.0 [Срок оценки: Enrollment (week 0) and post-intervention (week 10)]
• Affective attitudes assessed using items derived from Tang et al. (2023) [Срок оценки: Enrollment (week 0) and post-intervention (week 10)]
• Instrumental attitudes assessed using items derived from Tang et al. (2023) [Срок оценки: Enrollment (week 0) and post-intervention (week 10)]
• Perceived opportunity assessed using items derived from Tang et al. (2023) [Срок оценки: Enrollment (week 0) and post-intervention (week 10)]
• Perceived capability assessed using items derived from Tang et al. (2023) [Срок оценки: Enrollment (week 0) and post-intervention (week 10)]
• Intention strength assessed using items derived from Tang et al. (2023) [Срок оценки: Enrollment (week 0) and post-intervention (week 10)]
• Decisional intention assessed using item "I intend to increase 3000 steps above my baseline daily steps for most days per week." [Срок оценки: Enrollment (week 0) and post-intervention (week 10)]

Критерии участия

Критерии включения

AGE: 18-64 years DIAGNOSIS: A self-reported current diagnosis of major depressive disorder and/or at least mild depressive symptoms (>= 5) on the Patient Health Questionnaire, 9-Item (PHQ-9).

DEVICE: Possess an iPhone or Android smartphone with internet access to download the app.

LANGUAGE: Read, write understand, and communicate in the English language (or as appropriate)

Критерии исключения

• Are experiencing acute risk of harm to self or others
• Have an active alcohol or substance use disorder
• Physical disability preventing exercise
• Active psychosis or mania
• Severe cognitive impairment
• Current pregnancy
• Patients whose depression is directly linked to another major primary psychiatric disorder, such as psychosis or bipolar disorder
• Exercise >= 90 min moderate-vigorous physical activity per week or >= 3 times/week
• Anticipate a major absence (e.g., long vacation, surgery) in the next 3 months
• Anticipate a major change to participants' current antidepressant treatment regimen (if any, e.g., medications, psychotherapy) in the next 3 months

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Tang Y, Gierc M, La H, Kim J, Liu S, Lam RW, Puterman E, Faulkner G. MoodMover: Development and usability testing of an mHealth physical activity intervention for depression. Digit Health. 2025 Feb 3;11:20552076251317756. doi: 10.1177/20552076251317756. eCollection 2025 Jan-Dec. PMID 39906877
• Rhodes RE, Lim C. Understanding action control of daily walking behavior among dog owners: a community survey. BMC Public Health. 2016 Nov 16;16(1):1165. doi: 10.1186/s12889-016-3814-2. PMID 27852251
• Tang Y, Gierc M, Whiteford V, Rhodes RE, Faulkner G. Exploring correlates of physical activity using the multi-process action control framework: is there a moderating role for mental health? International Journal of Sport and Exercise Psychology. 2023:1-19. doi: https://doi.org/10.1080/1612197X.2023.2225515.
• Rovniak LS, Anderson ES, Winett RA, Stephens RS. Social cognitive determinants of physical activity in young adults: a prospective structural equation analysis. Ann Behav Med. 2002 Spring;24(2):149-56. doi: 10.1207/S15324796ABM2402_12. PMID 12054320
• Tang Y, Gierc M, La H, Liu S, Lam RW, Puterman E, Faulkner G. Feasibility and preliminary effects of an app-based physical activity intervention for individuals with depression (MoodMover): A protocol for a single-arm, pre-post intervention study. PLoS One. 2025 Apr 22;20(4):e0321958. doi: 10.1371/journal.pone.0321958. eCollection 2025. PMID 40261856

Идентификаторы

NCT: NCT06573125 · H24-01820

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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